Hexalen and Pregnancy
When Hexalen (altretamine) was given to pregnant animals, it appeared to cause miscarriages and birth defects. Due to these potential risks, this drug is considered a pregnancy Category D medicine, meaning it may cause harm to an unborn child if taken during pregnancy. It is generally recommended that women use an effective form of birth control during Hexalen treatment.
Hexalen® (altretamine) is a prescription medicine used in the treatment of ovarian cancer (cancer of the ovaries). This product is considered a pregnancy Category D medicine, which means it may cause harm to an unborn child if taken during pregnancy.
The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category D is a classification given to medicines that have been shown to present a risk to the fetus in studies of pregnant women but may still offer benefits that outweigh the risks the drug presents. A pregnancy Category D medicine may still be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh the possible risks to her unborn child.
In animal studies, Hexalen caused miscarriages and birth defects when given to pregnant rats and rabbits. However, this drug has not been adequately studied in pregnant women.
It is generally recommended that women of childbearing potential use an effective form of birth control to avoid becoming pregnant during Hexalen treatment. Talk to your healthcare provider about the best birth control options for your particular situation.
If you are pregnant or thinking about becoming pregnant, let your healthcare provider know before starting treatment with Hexalen. He or she will consider the benefits and risks before making a recommendation for your particular situation.